৩ মে, ২০২৩
"The Alzheimer’s treatment donanemab, which is made by Eli Lilly, significantly slowed progression of the mind-robbing disease..."
"... according to clinical trial data released Wednesday by the company. Patients who received the monthly antibody infusion during an 18-month study demonstrated a 35% slower decline in memory, thinking and their ability to perform daily activities compared to those who did not receive the treatment, Eli Lilly’s data showed."
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Our biotech industry is our greatest industry, hands down.
Vivek was a biotech CEO. He invested in a drug that tried to cure Alzheimer’s, but it didn’t work.
I will be seeing Vivek next week.
I trust nothing from pharma. Look how tests are run, results are reported. Pharma controls it all. No, I'm not an anti-vax nut. Just read it. Not political
https://imprimis.hillsdale.edu/americas-broken-health-care-diagnosis-and-prescription/
Good.
Meanwhile, the most significant mind-robbing disease goes unchecked in America's benighted mutant colonies.
I bet the Eli Lilly lobbyists hand these out like candy on Capitol Hill and probably airlift quantities into Delaware each weekend.
CEO of LLY was just on CNBC. LLY is the second biggest Pharma company and the stock is up 6% pre market. Wow!
In the words of oh, some guy whose name I can't remember, faster, please! If this scourge is going to hit my husband and/or me, we probably have about twenty years.
Our parents seem ok so far, though each of us had one grandparents with dementia.
My heart goes out to all who suffer dementia and all who care for them.
The CEO of LLY is David Ricks. Like Meade, he is a Hoosier. Grad of both Purdue and Indiana. One impressive guy. LLY is one impressive company.
If slowing progression only means you get to live with Alzheimer's for a longer time this will be a mixed blessing.
ChatCNBC?
Complete response letter based on limited number of patients with 12-month drug exposure data in the accelerated approval submission; no other deficiencies were identified
...
Accelerated approval application was based on Phase 2 trial showing amyloid plaque lowering
...
the treatment cleared plaque quickly
“It should be unequivocal that drugs that remove plaque, particularly if you can remove plaque completely and do it quickly, can lead to very significant clinical benefits for patients,” Skovronsky said in an interview.
A contentious hypothesis with ambiguous support.
So you're Joe Biden in four years instead of three.
Last night, I was wondering about this article on the Alzheimer’s Association website:
WASHINGTON, D.C., May 1, 2023 — A bipartisan group of attorneys general from 26 states and territories are calling on the Biden administration to stop blocking access to Alzheimer’s treatments approved by the Food and Drug Administration (FDA). The bipartisan group sent a letter urging Health & Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure to reverse the unprecedented decision to block access to FDA-approved Alzheimer's drugs. Despite mounting bipartisan political pressure, CMS continues to deny Medicare beneficiaries living with early Alzheimer's access to critically important, FDA-approved medical treatments.
Now I know why the CMS will block Medicare clients from FDA approved drug. Also, the name of CMS administrator is definitely a good one for a novel.
Slowing progress does not mean a cure. I look forward to reading of further improvements in treatment.
Just give us some Adderall like all the young guns are taking. Then we'll be able to keep up!
It is great news though much of the buzz and stock pop was fizzing back in phase II. Fast tracked to be sure...
...and I haven't been keeping up on the details but keep in mind onset is generally late in life so a shallower glidescope of progression can mean the difference between disability and normalcy. I also suspect long term studies may/will likely show benefits have been understated..
"If slowing progression only means you get to live with Alzheimer's for a longer time this will be a mixed blessing."
An awful lot of the treatment of disease is about mitigating its effects and keeping you alive longer — cancer, Parkinson's, diabetes, etc. etc.
So many major diseases are treated but not cured.
Do you seriously have a problem with that?!
LLY has a $383B market cap. This is a huge move today.
In his interview on CNBC, LLY CEO Ricks said CMS won't approve. But here's the value equation: Pay LLY $10k (a guess by me) and avoid Medicare paying $100k for a year of memory care in a nursing home.
On days like this, I have hope. Proud to be an American.
Tip to Althouse community: TCRT. Cancer treatment: 6 indications including pancreatic and lung cancer.
Do your own DD.
Ann Althouse said...
So many major diseases are treated but not cured.
Do you seriously have a problem with that?!
kinda, yeah!
would YOU rather have cancer for 6 months, and die?
Or have cancer for 3 years of pain, suffering, and expense.. And THEN die?
Seriously, HOW LONG do You want to live? Past the point where you can go on your morning walks?
If your "life" consists of lying on a hospital bed, with tubes stuck in you?
A major caveat on TCRT. It is in Phase I. Big data releases this year. It could all go to hell or to zero.
LLY was in Phase III. Might get FDA approval this year.
The Joe Kernan interview of LLY CEO Ricks is really good. Solid info. Joe knows his science.
"Ann Althouse said...
An awful lot of the treatment of disease is about mitigating its effects and keeping you alive longer — cancer, Parkinson's, diabetes, etc. etc.
So many major diseases are treated but not cured."
So many is really nearly all. And that's a feature not a bug. Turning fatal diseases into chronic diseases is a money maker. Cures are like deaths. No money in it.
"Dave Begley said...
Our biotech industry is our greatest industry, hands down."
Were you in a coma during the pandemic? Fucking criminals.
Dr. Daniel Skovronsky, Lilly’s chief scientific and medical officer, said “Every day that goes by, there are some patients who pass through this early stage of Alzheimer’s disease and become more advanced and they won’t benefit from treatment...."
This is a drug for people whose brains show evidence of the disease:
"Nearly half of patients — 47% — who received donanemab showed no disease progression a year after treatment began, compared with 29% who did not receive the antibody, according to the data released Wednesday. More than half of patients completed the treatment in the first year and 72% completed it in 18 months due to clearance of brain plaque. In a separate measure, patients who received donanemab showed 40% less decline in their ability to conduct daily activities at 18 months. This means they could better manage finances, drive, pursue hobbies and hold conversations than those who did not receive the treatment.... Donanemab cleared the plaque at six months in 34% of patients who had intermediate levels of a protein called tau that can become toxic and kill neurons. At 12 months, donanemab cleared the plaque in 71% of patients with the same tau levels."
This is a big deal! I can't believe the negativity shown here. This is great news.
Given how untrustworthy the pharmaceutical industry, the CDC, and the FDA have shown themselves to be, anyone who isn't skeptical is hopelessly naive. This would be great news if it's true. And very cruel if it's not. While we wait to see, some people will make a great deal of money either way.
The original Eli Lilly was an artillery officer in the Civil War and was a hero at the battle of Hoovers Gap, TN. He went on to be a pharmacist.
In his interview with Joe Kernan, the LLY CEO said that LLY is working on a blood test to see if you have a genetic disposition or markers for Alzheimer's. Huge. Get the drug in your 50s or 60s and avoid grief latter.
Ann is correct. This is incredibly great news brought to you by American capitalism.
It would be interesting to know how many billions LLY spent over the years to get to this point.
This ain't happening in Russia or China. Or even in Europe.
Before everyone continues this orgy of speculative enthusiasm and criticism, I suggest getting up to speed on some history. I recommend starting at Derek Lowe's place:
https://www.science.org/blogs/pipeline
Ha, Fred Drinkwater! I came here to put the same link. Derek is the man.
Concur with Fred Drinkwater. Pipeline is a good resource. As we learned during covid, human studies and the statistics around them are very hard. In the case of Alzheimer's, there was a lot of hope around controlling amyloid plaques, but despite an enormous amount of effort, nothing seems to have come of it. As one who's spent 15 years of his life on dealing with the fallout of dementia, I certainly take no pleasure in that. But for the nonce we basically know nothing. Maybe donanemab will prove out but let's wait on critical analysis before building up (yet again) too much hope. Lowe's palpable dismay at the approval of lecanemab is worth reviewing.
While promising- the study does suggest beta-amyloid plaques are at least a factor in the disease itself, something was beginning to be doubted due to the lack of efficacy of other mono-clonal antibodies failing at the Phase III stage- I think a 35% reduction in a rate of disease progression isn't any great improvement. Instead of ending up with full blown dementia in, let's say 2 years, it takes 3 years on the drug.
It will get approved on these results, if they hold up on deeper analysis, and it will hopefully help some people more than just 35%.
This is statistically insignificant, and is contentious with other studies performed with the same hypothesis. The drug reduces plaque formation, with serious adverse events, and the claim to treat Alzheimer's has yet to be demonstrated, which is probably why the FDA rejected their first application. There may be reason to be optimistic, but it lacks reason and empathy to promote it to people who are affected.
My skepticism is based on the results from two other mono-clonal antibody (MAB) treatments attacking beta-amyloid- aducanumab and lecanemab. Both of those previous studies indicated that the MABs cleared the plaques- the first of those, aducanumab has shown no real efficacy in progression of Alzheimers, and lecanemab showed only a modest reduction in disease progression. So, on these three results, all three cleared the plaques, but you see variable disease progression results. This suggests that:
(1) there is a great deal of inherent variability in the outcome analysis, and it probably arises because assessing mental fitness has a large subjective component to it;
(2) it might well be that amyloid plaques aren't the cause, but are, rather, a symptom of whatever process drives Alzheimers.
Note to Ian Nemo above- I haven't read what Lowe said about lecanemab, so it is possible he didn't want it approved by the FDA either, but I have read his scathing attack on the approval of aducanumab. The Phase III studies of both were different- lecanemab had a more promising disease progression outcome (I will try later to compare it to the Eli Lilly results later if I have time) compared to aducanumab.
Sometimes, yes, I have a problem with mitigating a horrible disease to extend the time a person can live in a horrible state. I’ve spent my entire career in the Pharma industry. I am familiar with countless clinical trials. Drugs come with horrible side effects. Things are not always what they seem.
Every patient should make their own treatment decisions based on a clear understanding of the consequences. But can a dementia patient do this? Would a dementia patient want to extend the time on earth living in the slowed downward spiral? That was my point. To me it is a mixed blessing. I am not saying it is a bad thing per se, but I am saying that for some patients it will be.
Something tells me David Begley owns some LLY stock.
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